BIOGLUE SYRINGE 5-PACK, 2ML
Report
- Report Number
- 1063481-2025-00122
- Event Type
- Injury
- Date Received
- December 23, 2025
- Date of Event
- October 23, 2025
- Report Date
- March 9, 2026
- Manufacturer
- ARTIVION, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
THE MANUFACTURING RECORDS FOR BG3502-5-G, LOT BG001380 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THE USE OF ¿BIOGLUE ON THE SURGICAL BED OF MEDIASTINAL LYMPHADENECTOMY¿ IS OFF LABEL. A LYMPHATIC SURGICAL BED IS NOT CONSIDERED PULMONARY TISSUE. IN ADDITION, THE BIOGLUE USE IN THIS SCENARIO IS NOT AN ADJUNCT TO SUTURE CLOSURE. IN ADDITION TO THE INDICATION STATEMENT NOT SUPPORTING LYMPHATIC USE, THE IFU ALSO SAYS ¿THE SUITABILITY OF BIOGLUE FOR TREATMENT OF BRONCHOPLEURAL FISTULA (BPF) OR LYMPHATIC LEAKAGE IS NOT CONFIRMED BY SUFFICIENT DATA.¿ OFF LABEL USE OF BIOGLUE IS NOT RECOMMENDED OR SUPPORTED BY ARTIVION. ANATOMICALLY, THE DEGRADATION AND ABSORPTION OF BIOGLUE ON LYMPHATIC TISSUE BED CANNOT BE ASSUMED TO BE EQUIVALENT TO BLOOD VESSELS OR SOFT TISSUE IN INDICATED PROCEDURES. THE PHYSICIAN REFERENCES READING AN UNNAMED ARTICLE. LITERATURE SEARCH REVEALS THAT BIOGLUE USE IN LYMPHATIC SCENARIOS HAVE BEEN REPORTED. ONE REFERENCE, PASSAGE 2005, APPEARS TO DESCRIBE BIOGLUE IN LYMPHATIC PROCEDURES WITH SATISFACTORY RESULTS. REGARDLESS OF PUBLISHED LITERATURE, THIS USE CASE IS OFF LABEL AND NOT SUPPORTED. THIS DOES NOT REPRESENT A NEW OR UNEXPECTED ADVERSE EVENT. THE BIOGLUE AFMEA AND DFMEA WERE REVIEWED. THE REPORTED EVENTS ARE ADDRESSED IN AFMEA, HAZARD STEP/ITEM # A. 1-47A. THE REPORTED PRODUCT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR LOT # BG001380 WAS PERFORMED. NO ISSUES WERE FOUND THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. USE OF ¿BIOGLUE ON THE SURGICAL BED OF MEDIASTINAL LYMPHADENECTOMY¿ IS OFF LABEL. A LYMPHATIC SURGICAL BED IS NOT CONSIDERED PULMONARY TISSUE. IN ADDITION, THE BIOGLUE USE IN THIS SCENARIO IS NOT AS AN ADJUNCT TO SUTURE CLOSURE. IN ADDITION TO THE INDICATION STATEMENT NOT SUPPORTING LYMPHATIC USE, IFU ALSO SAYS ¿THE SUITABILITY OF BIOGLUE FOR TREATMENT OF BRONCHOPLEURAL FISTULA (BPF) OR LYMPHATIC LEAKAGE IS NOT CONFIRMED BY SUFFICIENT DATA.¿ OFF-LABEL USE OF BIOGLUE IS NOT RECOMMENDED OR SUPPORTED BY ARTIVION. ANATOMICALLY, THE DEGRADATION AND ABSORPTION OF BIOGLUE ON LYMPHATIC TISSUE BED CANNOT BE ASSUMED TO BE EQUIVALENT TO BLOOD VESSELS OR SOFT TISSUE IN INDICATED PROCEDURES. THE PHYSICIAN REFERENCES READING AN UNNAMED ARTICLE. LITERATURE SEARCH REVEALS THAT BIOGLUE USE IN LYMPHATIC SCENARIOS HAVE BEEN REPORTED. ONE REFERENCE, PASSAGE 2005, APPEARS TO DESCRIBE BIOGLUE IN LYMPHATIC PROCEDURES WITH SATISFACTORY RESULTS. REGARDLESS OF PUBLISHED LITERATURE, THIS USE CASE IS OFF-LABEL AND NOT SUPPORTED. THIS DOES NOT REPRESENT A NEW OR UNEXPECTED ADVERSE EVENT. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THE USE OF ¿BIOGLUE ON THE SURGICAL BED OF MEDIASTINAL LYMPHADENECTOMY¿ IS OFF LABEL. A LYMPHATIC SURGICAL BED IS NOT CONSIDERED PULMONARY TISSUE. IN ADDITION, THE BIOGLUE USE IN THIS SCENARIO IS NOT AN ADJUNCT TO SUTURE CLOSURE. IN ADDITION TO THE INDICATION STATEMENT NOT SUPPORTING LYMPHATIC USE, THE IFU ALSO SAYS ¿THE SUITABILITY OF BIOGLUE FOR TREATMENT OF BRONCHOPLEURAL FISTULA (BPF) OR LYMPHATIC LEAKAGE IS NOT CONFIRMED BY SUFFICIENT DATA.¿ THE MANUFACTURING RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION- FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT, THE SURGEON RELAYED THE FOLLOWING: I AM ONE OF THE THORACIC CONSULTANTS AT THE (B)(6) AND I'M CONTACTING YOU AS (I'M TOLD) YOU'RE THE REP FOR BIOGLUE. I HAVE USED BIOGLUE ON THE SURGICAL BED OF MEDIASTINAL LYMPHADENECTOMY AFTER LUNG RESECTION IN ABOUT 20 PTS IN THE LAST YEAR (FOLLOWING A PAPER I READ SOME TIME AGO MENTIONING BIOGLUE CAN REDUCE LYMPHATIC LEAK AFTER MEDIASTINAL LYMPHADENECTOMY). I HAVE HAD 2 PATIENTS DEVELOPING A PARTICULARLY NASTY SORT OF FOREIGN BODY REACTION TO THE BIOGLUE IN THE SUBCARINAL AREA AND DEVELOPING, ABOUT 3 MONTHS AFTER SURGERY, AN INFLAMMATORY MASS THAT CAUSED STENOSIS FROM EXTERNAL COMPRESSION AND FINALLY EROSION INTO THE LEFT MAIN BRONCHUS, REQUIRING THORACOTOMY AND AIRWAY REPAIR. IN BOTH CASES, THE 'INFLAMMATORY MASS' WAS MADE OF A CORE OF BIOGLUE COVERED IN FIBROSIS. I AM ATTACHING SOME BRONCHOSCOPY PICTURES AND A PICTURE OF THE REMOVED BIOGLUE FRAGMENTS. I STOPPED USING THE BIOGLUE ALTOGETHER SINCE AUGUST BECAUSE OF THIS. I WAS NOT AWARE OF THIS POTENTIAL SIDE EFFECT BUT I HAVE FOUND SOME PUBLISHED CASE REPORTS ON THIS FROM OTHER SPECIALTIES. I WANTED TO ASK IF YOU HAD ANY MORE INFORMATION OR ADVICE ON THIS. THIS INVESTIGATION IS RELEGATED TO BIOGLUE PRODUCT CODE: UNKNOWN, LOT NUMBER: UNKNOWN WITH ALLEGATION OF INFLAMMATORY RESPONSE.
ACCORDING TO THE INITIAL REPORT THE SURGEON RELAYED THE FOLLOWING: I AM ONE OF THE THORACIC CONSULTANTS AT (B)(6) AND I'M CONTACTING YOU AS (I'M TOLD) YOU'RE THE REP FOR BIOGLUE. I HAVE USED BIOGLUE ON THE SURGICAL BED OF MEDIASTINAL LYMPHADENECTOMY AFTER LUNG RESECTION IN ABOUT 20 PTS IN THE LAST YEAR (FOLLOWING A PAPER I READ SOME TIME AGO MENTIONING BIOGLUE CAN REDUCE LYMPHATIC LEAK AFTER MEDIASTINAL LYMPHADENECTOMY). I HAVE HAD 2 PATIENTS DEVELOPING A PARTICULARLY NASTY SORT OF FOREIGN BODY REACTION TO THE BIOGLUE IN THE SUBCARINAL AREA AND DEVELOPING, ABOUT 3 MONTHS AFTER SURGERY, AN INFLAMMATORY MASS THAT CAUSED STENOSIS FROM EXTERNAL COMPRESSION AND FINALLY EROSION INTO THE LEFT MAIN BRONCHUS, REQUIRING THORACOTOMY AND AIRWAY REPAIR. IN BOTH CASES, THE 'INFLAMMATORY MASS' WAS MADE OF A CORE OF BIOGLUE COVERED IN FIBROSIS. I AM ATTACHING SOME BRONCHOSCOPY PICTURES AND A PICTURE OF THE REMOVED BIOGLUE FRAGMENTS. I STOPPED USING THE BIOGLUE ALTOGETHER SINCE AUGUST BECAUSE OF THIS. I WAS NOT AWARE OF THIS POTENTIAL SIDE EFFECT, BUT I HAVE FOUND SOME PUBLISHED CASE REPORTS ON THIS FROM OTHER SPECIALTIES. I WANTED TO ASK IF YOU HAD ANY MORE INFORMATION OR ADVICE ON THIS. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON: MALE, 68Y OLD. 1. LOT BG001380. EXP 9.5.26. REF BG3502-5-G, 2ML. 2. IMPLANT OPERATION ¿ LEFT ROBOTIC UPPER LOBECTOMY FOR LUNG CANCER AFTER NEOADJUVANT CHEMOIMMUNOTHERAPY. 3. DATE OF IMPLANT - (B)(6) 2025; DATE OF EXPLANT (B)(6) 2025. NO SENSITIVITY KNOWN TO MATERIALS OF BOVINE ORIGIN. THIS INVESTIGATION IS RELEGATED TO BIOGLUE PRODUCT CODE: BG3502-5-G, 2ML, LOT NUMBER: BG001380 WITH ALLEGATION OF INFLAMMATORY RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549908 | BIOGLUE SYRINGE 5-PACK, 2ML | GLUE, SURGICAL, ARTERIES | MUQ | ARTIVION, INC. | BG3502-5-G | BG001380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Other| R |